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 Class 2 Recall
LATITUDE® Communicator		see related information
Date Posted November 12, 2009
Recall Number Z-0180-2010
Product Guidant LATITUDE® Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE® Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE® Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
Code Information SERIAL NUMBERS: 029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519, 603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067, 055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895, 602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034, 063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973, 063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499, 039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812 024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180.
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Reason for
Recall		 The L ATITUDE¿ communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It
Action Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000.
Quantity in Commerce 97
Distribution Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.
 
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